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Efficacy of NovoSeven® in Bleeding Prophylaxis in Hemophilia

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: April 18, 2005
Last updated: January 11, 2017
Last verified: January 2017

This trial is conducted in Africa, Asia, Europe, South America, and the United States of America (USA).

The purpose of this study is to evaluate the effectiveness of secondary prophylactic treatment with NovoSeven® in haemophilia A and B patients with inhibitors.

Condition Intervention Phase
Congenital Bleeding Disorder
Haemophilia A With Inhibitors
Haemophilia B With Inhibitors
Drug: activated recombinant human factor VII
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Exploratory, Multi-centre, Randomised, Double-blind, Uncontrolled Trial Evaluating the Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Secondary Bleeding Prophylaxis in Congenital Haemophilia A or B Patients With Inhibitors

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Reduction of bleeds [ Time Frame: During 3 months treatment period as compared to 3 months observation period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy variables [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: March 2004
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of congenital haemophilia A or B with inhibitors development against FVIII or FIX, respectively

Exclusion Criteria:

  • Prophylactic administration of any haemostatic drug within 3 last months prior to entering the trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00108758

  Show 37 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT00108758     History of Changes
Other Study ID Numbers: F7HAEM-1505 
Study First Received: April 18, 2005
Last Updated: January 11, 2017
Health Authority: Bulgaria: Ministry of Health
Spain: Spanish Agency of Medicines
Russia: Pharmacological Committee, Ministry of Health
Turkey: Ministry of Health
Brazil: National Health Surveillance Agency
Poland: Ministry of Health
Romania: State Institute for Drug Control
South Africa: Medicines Control Council
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia
Philippines: Bureau of Food and Drugs
United States: Food and Drug Administration

Additional relevant MeSH terms:
Hemophilia A
Hemophilia B
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Pathologic Processes
Genetic Diseases, X-Linked
Vascular Diseases
Cardiovascular Diseases processed this record on January 14, 2017